Metastatic Breast CancerPhase 1NCT02524951
Safety and Tolerability of MSI-1436C in Metastatic Breast Cancer
A Phase 1 study testing MSI-1436C in people with Metastatic Breast Cancer, run by Northwell Health at 1 site in United States.
Trial summary
This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- MSI-1436C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 14 May 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination.
- A metastatic site must be biopsy proven
- Life expectancy ≥3 months.
- Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.
- Female Age ≥18 years.
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- Stable brain metastasis is permitted. This is not considered measurable disease.
- Stable brain metastasis is defined as no change on CT scan or MRI for minimum of 2 months AND no change in steroid dose for a minimum of 4 weeks
- A negative serum pregnancy test, if female of reproductive potential. Reproductive potential defined as age < 55 or with no menses for < 1 year
- Screening laboratory values as follows:
- Total bilirubin ≤1.5 times upper limit of normal (ULN). Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvate transaminase)≤ 2.5 times ULN.
- Serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥60 mL/min. Absolute neutrophil count >1,500 cells/mm3. Platelet count ≥100,000 plt/mm3. Hemoglobin ≥ 8 g/dL. Non-diabetic
Who cannot join
- Pregnant or breast-feeding
- ECOG Performance Status greater than 2
Trial locations and contacts
1 site in 1 country.
United States1 site
CFAM / Monter Cancer Center
Lake Success, New York, 11042
About this study
Official title: A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients
This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
Read the detailed description
This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436. Drug infusions will last approximately 2 hours. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436 will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.
- Conditions
- Metastatic Breast Cancer
- Being tested
- MSI-1436C
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSI-1436CDrug
Also called Trodusquemine
Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| MSI-1436C (Trodusquemine) 20 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 20 mg/m2. Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
| MSI-1436C (Trodusquemine) 26 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 26 mg/m2. Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
| MSI-1436C (Trodusquemine) 34 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 34 mg/m2 . Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
| MSI-1436C (Trodusquemine) 44 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 44 mg/m2 . Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
| MSI-1436C (Trodusquemine) 57 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 57 mg/m2. Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
| MSI-1436C (Trodusquemine) 74 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 74 mg/m2 . Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
| MSI-1436C (Trodusquemine) 96 mg/m2 IV | Experimental | Open label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 96 mg/m2 . Drug infusions will last approximately 2 hours. Receives: Drug: MSI-1436C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally Tolerated Dose (MTD) of MSI-1436
Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436C. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436C will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.
Measured: one year
Secondary outcomes (6)
Area under the plasma concentration versus time curve (AUC)
The area under the plasma drug concentration-time curve (AUC) reflects the actual body exposure to drug after administration of a dose of MSI-1436C.
Measured: one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
All adverse events and dose-limiting toxicities will be recorded and tabulated. A dose-limiting toxicity (DLT) will be defined as any grade 3 or higher NCI Common Toxicity Criteria adverse event (CTCAE) that is deemed related to the study drug MSI-1436C, any infusion reaction necessitating drug discontinuation, or any other drug related adverse event leading to the study drug discontinuation.
Descriptive statistics will be used to summarize adverse events and dose-limiting toxicities. The proportion of AEs and DLTs will be calculated along with their corresponding exact 95% confidence intervals.
Measured: one year
response rates
To assess the response rates of MSI-1436C in metastatic breast cancer patients the outcome variable of interest is time-to-progression. Patients who have not progressed (or who have not died) as of their last known follow-up, will be considered 'censored' for the time-to-progression analysis.
Time-to-progression will be estimated using the Kaplan-Meier Product-Limit Method. Any post- hoc group comparisons will be carried out using the log-rank test. Patients who have not progressed (or who have not died) as of their last known follow-up, will be considered 'censored' for the time-to-progression analysis.
Measured: one year
Peak plasma concentration of the drug after administration (cmax)
The maximum (or peak) serum concentration that MSI-1436C achieves in the plasma after the drug has been administrated and prior to the administration of a second dose.
Measured: one year
Time to reach cmax
The amount of time for MSI-1436C to reach Cmax
Measured: one year
Time required for the concentration of MSI-1436C to reach half of its original value, or half life (t1/2)
The time required for the concentration of MSI-1436C to reach half of its original value.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startApr 2016
- Primary completionJul 2017
- Study completion14 May 2018
Why it stopped: lack of interest by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- DepYmed Inc.
- Responsible party
- Principal investigator, Daniel Budman, Northwell Health
- Investigators
- Daniel Budman, MD, Principal investigator, North Shore LIJ Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02524951
- Sponsor's protocol ID
- IIS-0039
- Status last verified
- May 2018
- First submitted
- 12 Aug 2015
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Tolerability of Single Agent MSI-1436C in Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02524951
- Acronym / sponsor ID
- IIS-0039
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of interest by sponsor
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- DepYmed Inc.
- Study start
- Apr 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 17 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
Detailed description
This is a Phase I, open-label, dose escalation study. MSI-1436 will be administered as a single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436. Drug infusions will last approximately 2 hours. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436 will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| MSI-1436C (Trodusquemine) 20 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 20 mg/m2. Drug infusions will last approximately 2 hours. |
| MSI-1436C (Trodusquemine) 26 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 26 mg/m2. Drug infusions will last approximately 2 hours. |
| MSI-1436C (Trodusquemine) 34 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 34 mg/m2 . Drug infusions will last approximately 2 hours. |
| MSI-1436C (Trodusquemine) 44 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 44 mg/m2 . Drug infusions will last approximately 2 hours. |
| MSI-1436C (Trodusquemine) 57 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 57 mg/m2. Drug infusions will last approximately 2 hours. |
| MSI-1436C (Trodusquemine) 74 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 74 mg/m2 . Drug infusions will last approximately 2 hours. |
| MSI-1436C (Trodusquemine) 96 mg/m2 IV | Experimental | Drug: MSI-1436COpen label, interventional, dose escalation of MSI-1436 (Trodusquemine), single intravenous infusion twice a week for 3 weeks on a 4-week cycle. Subjects will receive MSI-1436 at a dose of 96 mg/m2 . Drug infusions will last approximately 2 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed, witnessed, and dated Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Pathologically confirmed metastatic breast cancer with measurable disease. Metastatic sites must be measurable on CT, MRI, or FDG-PET/CT as per the revised RECIST v1.1 criteria or measurable disease on physical examination.
- A metastatic site must be biopsy proven
- Life expectancy ≥3 months.
- Patients enrolled must have received 2 or more lines of therapy and all patients with HER2 expressing tumors must have received HER2 targeted therapy.
Key exclusion criteria (2 listed)
- Pregnant or breast-feeding
- ECOG Performance Status greater than 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSI-1436CAlso: TrodusquemineDose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle. | Drug | MSI-1436C (Trodusquemine) 20 mg/m2 IV, MSI-1436C (Trodusquemine) 26 mg/m2 IV, MSI-1436C (Trodusquemine) 34 mg/m2 IV, MSI-1436C (Trodusquemine) 44 mg/m2 IV, MSI-1436C (Trodusquemine) 57 mg/m2 IV, MSI-1436C (Trodusquemine) 74 mg/m2 IV, MSI-1436C (Trodusquemine) 96 mg/m2 IV |
Primary outcome
Maximally Tolerated Dose (MTD) of MSI-1436
Time frame: one year
Subjects will be enrolled according to a standard Phase I Fibonacci design to receive MSI-1436C. If a subject has a dose-limiting toxicity (DLT) at any time during the study, MSI-1436C will be held and either re-started or discontinued in that subject as per the Dose Adjustments and Toxicities Guidelines.
6 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: one year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: one year
response rates
Time frame: one year
Peak plasma concentration of the drug after administration (cmax)
Time frame: one year
Time to reach cmax
Time frame: one year
Time required for the concentration of MSI-1436C to reach half of its original value, or half life (t1/2)
Time frame: one year
Results and safety
The study was stopped early (reason given: lack of interest by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Budman, MD principal investigator
North Shore LIJ Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSI-1436C in people with Metastatic Breast Cancer, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: lack of interest by sponsor). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximally Tolerated Dose (MTD) of MSI-1436 (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2018.